Europe

UK Biobank partners with the EGA

Thursday, July 20, 2017

Genomic data from the 500,000 people participating in the UK Biobank initiative will be distributed via the European Genome–phenome Archive (EGA), a resource developed jointly by the European Bioinformatics Institute (EMBL-EBI) and the Centre for Genomic Regulation (CRG). UK Biobank provides extremely detailed, high-quality datasets on individuals. It is an unprecedented collection that offers endless possibility and substantial efficiency savings for biomedical research and understanding the causes of disease.

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Vertex gains reimbursement agreement in Italy for cystic fibrosis drug Orkambi

Friday, July 14, 2017

Vertex Pharmaceuticals announced that the Italian Medicines Agency (Agenzia Italiana del Farmaco, or AIFA) has agreed to reimburse Orkambi (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The agreement is published online in the Italian Official Gazette.

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InVivo Therapeutics opens first U.K. INSPIRE Study site

Tuesday, July 11, 2017

InVivo Therapeutics announced that James Cook University Hospital in Middlesbrough, United Kingdom, has been added as the U.K.’s first clinical site for The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury. The Golden Jubilee Regional Spinal Cord Injuries Centre located at the James Cook University Hospital, a major trauma center, focuses exclusively on patients with spinal cord injuries and is one of eight specialist centers within England.

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LifeArc, previously MRC Technology, to invest £500M

Thursday, June 15, 2017

LifeArc, the U.K. medical research charity previously known as MRC Technology, announced plans to improve the lives of patients suffering from diseases that present the greatest challenges to medical research. By investing up to £500 million over the next five years, LifeArc will seek to generate, fund and champion innovations in antimicrobials, neuroscience, personalized oncology and respiratory medicine.

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Pharmacovigilance in the Russian Federation

Thursday, June 15, 2017

In the Russian Federation, two codes of rules for pharmacovigilance are presently used. The local regulatory body responsible for pharmacovigilance is the Federal Service for Surveillance in Healthcare (RosZdravNadzor) and the Federal State Budgetary Institution named the Centre for Monitoring and Clinical Economic Expertise under the RosZdravNadzor.

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